Actively Recruiting
Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
Led by Instituto de Investigación Biomédica de Salamanca · Updated on 2026-04-21
1000
Participants Needed
4
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The CODEX-1 study is a multicenter retrospective observational study designed to assess the diagnostic performance of a novel software application for coronary artery disease (CAD) evaluation. The application integrates automated stenosis detection, CT-derived fractional flow reserve (CT-FFR), and plaque quantification, all performed on-site. A total of 1,000 patients who previously underwent coronary computed tomography angiography (CCTA) and diagnostic invasive coronary angiography (ICA) and/or other non-invasive imaging will be included. The study compares the diagnostic outputs of the software to current clinical practice and expert adjudication, focusing on CAD-RADS categorization, prediction of the need for percutaneous coronary intervention (PCI), and reduction in unnecessary ICA procedures.
CONDITIONS
Official Title
Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Underwent coronary computed tomography angiography (CCTA) for diagnosis or assessment of coronary artery disease (CAD) between 2019 and 2024
- Availability of comparator diagnostic data within 1 month before or after the CCTA, including invasive coronary angiography (ICA), stress MRI, alternative CCTA analysis software, or documented clinical events
You will not qualify if you...
- Insufficient image quality to determine coronary stenosis or assess CAD parameters in routine clinical use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Université Lyon 1
Villeurbanne, France
Actively Recruiting
2
Amsterdam University Medical Center (AUMC)
Amsterdam, Netherlands
Actively Recruiting
3
Cardiologie Centra Nederland (CCM)
Amsterdam, Netherlands
Actively Recruiting
4
Institute of Biomedical Research of Salamanca
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
Research Team
C
Candelas Pérez Del Villar Moro, PhD MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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